DEPUY IRELAND VELYS SAW HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Catalog Number 451570102 |
Device Problems
Positioning Problem (3009); Appropriate Term/Code Not Available (3191)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 08/15/2023 |
Event Type
malfunction
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Event Description
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This is report 2 of 2 for the same event.It was reported that during a total knee arthroplasty surgical procedure, it was observed that while using the robotic-assisted saw handpiece device (x2) there were issues while making the cuts.It was reported that the chamfer cuts were over resected.There were no delays in the procedure.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.Additional information received from the reporter, reported that it was felt that the saw handpiece caused much "sloppiness".It was also reported that the pointer was not used for each and every cut.Hauptstrasse 24.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was evaluated and no defects or issues were observed with the system or software.Review of the event logs for this case did not confirm the described event of over resecting on the chamfer cuts.The investigation found the pointer measured the anterior chamfer cut with the expected performance of the system.The exact root cause for the reported issue could not be established because the issue was not confirmed, and no failure was observed.
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